Low-cost ambulatory medical pump

ABSTRACT

A low-cost medical pump for ambulatory use provides reduced life components combined with a pump lockout enforcing a safe operating limit and preventing reuse after that limit is exceeded. An improved IV line clamp portion minimizes unsupported clamp structure length and provides a dual lock system preventing inadvertent clamp release.

CROSS-REFERENCE TO RELATED APPLICATION Background of the Invention

The present invention relates to compact infusion pumps for ambulatoryuse and in particular to an infusion pump design to reduce the costs ofmedical care delivery.

Medical pumps, such as infusion pumps, are known for computer-controlleddelivery of medication (henceforth medicaments) to patients over aperiod of time. Recently, battery-powered compact infusion pumps havebecome available that permit the patient to remain active (ambulatory),for example, in a home environment away from a clinic or hospital duringthe treatment.

Typically the medicament is provided in a flexible bag that may beconnected to an IV line which in turn attaches to a needle or portcommunicating with the patient. A nurse or other healthcare professionalministering to the patient receives the medicament, reviews themedicament description for correctness, and enters the desired dose andrate into the pump. The IV line is then installed in the portable pumpand the assembly placed in a pack or other carrying apparatus that maybe retained on the patient. The medicament may be delivered as thepatient proceeds through normal life activities until the full dose iscomplete. The patient may then return the assembly to the nurse orhealth care professional who may provide a new bag of medicament and IVline, and may reprogram the pump for new treatment.

Pumps suitable for ambulatory use can have high total operating costsdriven in part by the cost of the pump itself which must meet exactingmedical standards while being compact, lightweight, and ruggedized forportable use. The present inventors have determined further that therecovery rate of ambulatory pumps is historically low. Failure torecover the pump can occur when pumps are used in end-of-life treatment,or are damaged or lost in the field.

High operating costs associated with ambulatory pumps necessarily limitthe availability of the use of such medical devices to some individualseven though the pump could greatly improve the quality of care.

SUMMARY OF THE INVENTION

The present invention provides a cost-reduced ambulatory pump intendedto increase availability and acceptability of ambulatory infusion. Lowercost is obtained by designing the pump with a component's shortoperating life specification, recognizing that the field operating lifeof such pumps is relatively short as biased by low pump recovery rates.Safety is ensured by incorporating absolute operating life limits intothe pump that prevent the pump from being used in excess of its designlife. In particular, maximum pump volume and maximum operating time maybe monitored and used to block further use of the pump if that use wouldexceed safe operating limits. The pump also provides an improved IV lineclamp system reducing the material costs of a significant mechanicalcomponent of the pump.

Specifically, the invention provides an ambulatory infusion pump havinga housing that holds an IV line support structure receiving an IV lineset and a fluid pump communicating with the IV support structure to pumpfluid through an IV line. The housing also includes an electroniccomputer commuting with the fluid pump and with a user interface forreceiving programming commands from a clinician. During operation, theelectronic computer monitors operation of the fluid pump to store atleast one cumulative pump operation value indicating a cumulativeoperation of the fluid pump from a time of manufacture. The computerdetermines whether an amount of operation of the fluid pump necessary toimplement received treatment protocol instructions will exceed thesoftware-enforced service life of the ambulatory fluid pump reduced byat least one cumulative pump operation value, and if so, preventsfurther operation of the fluid pump.

It is thus a feature of at least one object of the invention to providelook-ahead lockout of the programming of the pump, and when suchprogramming is for a treatment protocol that would exceed the designpump operating life value, such design pump operating life is set toallow the safe use of durability components.

The computer may further provide an indication to an individualproviding the fluid pump operation instructions through the userinterface that the pump has rejected the received treatment protocolinstructions.

It is thus a feature of at least one embodiment of the invention toclearly indicate the occurrence of the lockout, for example, so that itis not interpreted as the need for service, increasing pump-associatedcosts.

The software-enforced service life and at least one cumulative pumpoperation value cannot be reset using the user interface.

It is thus a feature of at least one embodiment of the invention toprevent unauthorized recycling of unsafe pumps or unsafe modification ofthe pump.

The indication may be a visual display

It is thus a feature of at least one embodiment of the invention to makeuse of a pre-existing user program element to provide an indication ofpump lockout.

The software-enforced service life and at least one cumulative pumpoperation value may be stored in nonvolatile memory.

It is thus a feature of at least one embodiment of the invention toreduce the chance of inadvertent or intentional resetting of the servicelimits by removing power from the pump.

The software-enforced service life and at least one cumulative pumpoperation value are stored so that they cannot be altered withoutdisassembly of the pump to access internal electronic components.

It is thus a feature of at least one embodiment of the invention toprovide hardware barriers to reuse of the pump beyond its safe servicelife.

The software-enforced service life and at least one cumulative pumpoperation value may be in units of volume of fluid pumped by the fluidpump.

It is thus a feature of at least one embodiment of the invention toprovide a measure of pump operation which reveals wear of the criticalpump element.

The software-enforced service life may be less than 100 liters.

It is thus a feature of at least one embodiment of the invention tolimit pump operation to permit the use of lower-cost pump elementssubject to more rapid wear, for example, employing lower-cost motors,simpler bearings and less expensive material subject to wear.

Alternatively or in addition, the software-enforced service life and atleast one cumulative pump operation value may be units of time ofoperation of the fluid pump.

It is thus a feature of at least one embodiment of the invention toprovide a measurement of pump field life that reveals exposure of thepump to environmental contaminants and the aging of pump componentsregardless of wear.

The software-enforced service life may be less than 1000 hours.

It is thus a feature of at least one embodiment of the invention tolimit pump operation to accommodate pump element contamination andmaterial aging.

The software-enforced service life and at least one cumulative pumpoperation value may be a combination of volume of fluid pumped by thefluid pump and time of operation of the fluid pump, and the program maycompare both a volume of fluid to be pumped by the fluid pump against avolume of fluid of the software-enforced service life and compare a timeof operation of the fluid pump against a time of operation of theambulatory fluid pump, each service life reduced by respectivecumulative pump operation values. When the amount of operation of thefluid pump necessary to implement the treatment protocol exceeds eitheradjusted software-enforced service lives, operation of the fluid pump isprevented.

It is thus a feature of at least one embodiment of the invention tocombine two measures of service life together to provide a more robustdefinition of the life of the pump.

The program may further operate to allow entry through the userinterface of a maximum flow rate for delivering medicament.

It is thus a feature of at least one embodiment of the invention topermit other safeguards to be determined by the clinician programmingthe pump.

The user interface may consist solely of manually operated electronicswitches for the purpose of receiving user input.

It is thus a feature of at least one embodiment of the invention toprovide a cost-reduced control commensurate with the desired low-costdesign of the pump.

The computer program may further execute to require entry of a passwordsequence through the user interface for accepting or changing treatmentprotocol instructions.

It is thus a feature of at least one embodiment of the invention toprovide pump programming consistent with use in an unsupervised setting.

The password sequence may make use of manually operated switches labeledfor other purposes.

It is thus a feature of at least one embodiment of the invention toprovide for password-secured settings without the need for additionalpassword input capabilities.

In some embodiments, the housing may provide a generally rectangularvolume having a an upper active portion and a lower clamp portionattachable to the upper active portion to hold the IV line therebetweenextending along a longitudinal axis, and the upper active portion andlower clamp portion may releasably attach to each other at multiplepoints along opposed longitudinal interfacing edges.

It is thus a feature of at least one embodiment of the invention toprovide a more robust IV line clamping system by minimizing theunsupported span of the clamp portion.

The upper active portion and lower clamp portion may releasably attachalong a front longitudinal edge by inter-engaging sliding hooks and tabswherein a front face of the housing exposes a slide operator movable ina first direction to slide the hooks, and a safety stop movable againsta spring in a second direction different from the first direction to astate allowing sliding of the hooks.

It is thus a feature of at least one embodiment of the invention tobetter prevent accidental disengagement of the clamp portion and IV lineduring ambulatory use.

These particular objects and advantages may apply to only someembodiments falling within the claims and thus do not define the scopeof the invention.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a simplified perspective view of the ambulatory pump assemblyas provided to a patient;

FIG. 2 is a front elevational view of the ambulatory pump showinginter-assembly of an upper active portion and lower clamp portion of thehousing as separated by operation of dual release elements and showing auser interface comprising a display and manually operated buttons;

FIG. 3 is a simplified block diagram of the electronics of the pump ofFIGS. 1 and 2 as controlled by internal electronic computer executing astored program;

FIG. 4 is a flowchart of the stored program of FIG. 3 and the datastructures used by that program;

FIG. 5 is a first fragmentary cross-sectional view taken along 5-5 ofFIG. 1 and a second perpendicular cross-section aligned therewithshowing operation of the dual release elements of FIG. 2; and

FIG. 6 is a perspective fragmentary view of the upper active portion andlower clamp portion as released showing various elements thereof.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to FIG. 1, an ambulatory pump 10 may operate inconjunction with a medicament bag 12 communicating with an IV line 14.The medicament bag 12 may be, for example, a flexible plastic bag of thetype used to hold IV solutions, and the IV line 14 provides a flexibletube allowing the flow of medicament from the medicament bag 12 and apatient connector 16 that may communicate with the patient through aneedle or port or the like. The IV line 14 may include a bubble filter17 for removing included air bubbles, limiting the need for air bubblesensing.

The ambulatory pump 10 provides a two-part housing having an upperelectronics portion 18 that may attach to a lower clamp portion 20 toreceive the IV line 14 therebetween along a longitudinal axis 22 beinggenerally the longest dimension of the housing of the ambulatory pump10. As so received, the ambulatory pump 10 may pump liquid through theIV line 14 by peristaltic action.

In one embodiment, the ambulatory pump 10 is constructed to weigh lessthan a half pound and preferably less than 1.5″×2″×5″ so as to be easilycarried by the patient, for example, in a pouch 24 also sized to receivethe medicament bag 12.

Referring now to FIG. 2, the housing of the upper active portion maypresent on its front surface a user interface 26 comprising, forexample, a liquid crystal type display 28 for displaying symbols andalphanumeric characters under computer control. The user interface 26also provides multiple membrane switch pushbuttons 30 that may beactivated by a user. Generally, the pushbuttons include a limited numberof controls including, in one embodiment, run and stop pushbuttons 30 aand 30 b, respectively, that will stop and start operation of the pumpas will be described below; a rate pushbutton 30 c allows setting of themaximum pumping rate of the ambulatory pump 10 in milliliters per hourby cycling through menu standard rates with each push (?). Thepushbuttons also include a “volume to be infused” pushbutton 30 dallowing user control of the maximum volume to be infused during atreatment protocol, also by cycling through standard settings with eachpush, as well as an information pushbutton 30 allowing the display ofdetailed information about the pump including remaining pump life (?).Pushbutton 30 f allows the unit to be turned on and off to conservepower. A bolus pushbutton 30 allows short operation of the pump todeliver medicament in fixed patient controlled bolus quantities (?).

A lower edge of the upper electronics portion 18 provides for a clamprelease slide 32 as will be described below and safety lock 34 that mustbe simultaneously activated to remove the lower clamp portion 20.

Referring now to FIG. 3, the ambulatory pump 10 may include amicrocontroller 36 being an electronic computer having a self-containednonvolatile memory 38 holding an operating program 40 and necessarystorage variables as will be described below. The nonvolatile memory maycomprise, for example, flash memory and/or read only memory, or othersimilar nonvolatile memory as context requires, which may store datavalues to be retained even in the absence of electrical power.

The microcontroller 36 also provides various inputs and output linescommunicating, for example, with the display 28 for providing displayinformation thereon and various pushbuttons 30 for receiving datarelated to their activation by user. In addition, the microcontroller 36may provide control lines to the pump assembly 42 having, for example,an internal DC electric motor (not shown) operating through a gearsystem to activate peristaltic plunger elements 44 that may pressagainst the contained IV line 14 to push fluid therethrough. As isunderstood in the art, generally the peristaltic plunger elements 44extend in an undulating serpentine fashion to compress and release thetubing thereby moving fluid therethrough.

The microcontroller 36 may also communicate electrically with varioussensors. For example, upstream and downstream pressure sensors 46 and 48which can be used to ensure proper operation of the pump by detectingabnormal pressures. Generally each of the pressure sensors 46 and 48 mayprovide a spring-loaded plunger that presses into the outer wall of theIV line 14 to sense pressure. This through-wall measurement avoids theneed for separate connections to the fluid-contacting pressure sensorand the problems of sterilization of a fluid-contacting pressure sensor.In such a through-tubing sensing system, the spring-loaded plungerdeforms a portion of a wall of the IV line 14 as held against abackstop. Under a known spring biasing force, the amount of deflectionof the wall may be measured to deduce internal pressure. Generally,lower pressures of the contained medicament will allow greaterdeflection of the wall of the IV line 14 and higher pressures ofcontained medicament will allow less deflection of the wall of the IVline 14. The system may be calibrated for a particular material of theIV line 14.

All electrical components in the upper electronics portion 18 maybesupplied with power by a contained storage battery 49 that may provideits power directly or through standard power processing circuits such asregulators and the like.

Referring now to FIG. 4, during normal operation, a clinician will entera total volume to be infused 52 and an infusion rate 54, as shown byprocess block 50, by using the user interface 26 shown in FIG. 2. Inorder to prevent tampering or inadvertent change in these values, theirentry is accomplished through a password which must be entered first,indicated by process block 56. The password may employ a predeterminedsequence of pressing of the pushbuttons 30 (for example, after the unitis turned on but before it is programmed) such as pressing the runpushbutton 30 a once and the stop pushbutton 30 b twice. Such use of thepushbuttons 30 may be without regard to the actual labels of the buttonas, in this example, “run” and “stop”.

The total volume to be infused 52 and the infusion rate 54 are then usedto compute a total infusion time 58 that may, but need not be, acontinuous time period but which may also be a cumulative time necessaryfor the infusion, contemplating that the infusion may be started andstopped by the patient. The total volume to be infused 52 and theinfusion time 58 represent received protocol instructions (either director indirect) from a clinician describing the intended operating limitsof the fluid pump in a treatment protocol.

At succeeding process block 60, the total volume to be infused 52 iscompared against a preset software-enforced volume limit 62 of the pump10 after the software-enforced volume limit 62 is reduced by thecumulative pumped volume 66. The cumulative pumped volume 66 is set tozero when the ambulatory pump 10 is manufactured and then increases withoperation of the pump assembly 42. Similarly, the total infusion time 58is compared against a preset software-enforced time limit 64 as reducedby the cumulative pump operation time 68. The cumulative pump operationtime is also set to zero when the ambulatory pump 10 is manufactured andthen increases with operation of the ambulatory pump 10 determined fromactivation of the on pushbutton 30 f not necessarily includingactivation of the pump assembly 42. The net effect of process block 60is to see if the intended treatment protocol can be performed before theservice life of the pump has been exceeded.

If either the use-adjusted, software-enforced volume limit 62 orsoftware-enforced time limit 64 have been exceeded, as determined atdecision block 70, the program 40 proceeds to process block 72 andprovides a warning that the treatment protocol may not be implemented asdisplayed on the display 28 of FIG. 2. The program 40 then returns theprocess block 50 without operation of the pump assembly 42 and a newpassword and new values must be entered if operation is to be continued.Decision block 70 may also check for adequate remaining battery energyfor the protocol using an internal time-to-ampere-hour conversions basedon the current drain of the ambulatory pump and comparing that againstthe estimated total ampere-hours of the battery.

If at decision block 70, the treatment protocol may be performed withinthe service limits of the pump 10, then the program proceeds to decisionblock 74 and may begin operation as indicated by process block 76, whenthe run pushbuttons 30 a is pressed. The program loops until the runpushbutton 30 a is pressed or the unit is switched off.

It will generally be understood that except through operation of theprogram 40 executing on the microcontroller 36, the values 66, 68, 62,and 64 contained in memory 38 may not be changed and the program 40 doesnot allow these values to be changed by the operator through the userinterface 26. More generally, these values may not be changed byremoving power from the ambulatory pump 10 (e.g. removing battery 49shown in FIG. 3) and generally require disassembly of the pump 10 toobtain direct access to the pin structure of the microcontroller 36 andspecialized equipment to access the memory directly if that is evenpossible. It is contemplated that these values may be stored in a waythat cannot be changed without destruction of the ambulatory pump 10 ormicrocontroller 36.

The operation of the pump at process block 76 will normally monitor thepressure sensors 48 and 46 to ensure there is no upstream or downstreamocclusion of medicament flow. Any such obstruction will cause a ceasingof the operation of the pump assembly 42 which may be reactivated aftercorrection by the user. During process block 76, pump flow-rate iscontrolled by controlling the speed of the pump assembly 42 in open loopfashion according to the entered infusion rate 54. During operation, thepump's 76 accumulated time and pumping volume per process block 77 areused to update cumulative pumped volume 66 and cumulative pump operationtime 68.

Periodically during operation of the pump at process block 76 (orenforced on an interrupt basis), decision block 78 may be polled to seeif the stop pushbutton 30 b has been pressed in which case the pumpassembly 42 stops and the program 40 returns to decision block 74.

If the stop pushbutton 30 b of decision block 78 has not been pressed,the program 40 proceeds to decision block 80 to determine whether thetotal volume through the ambulatory pump 10 during this treatmentprotocol has reached the total volume to be infused 52. If so, theprogram 40 loops back to process block 50, but if not the programreturns to process block 76.

It should be noted that the updating of the cumulative values perprocess block 77 looks at actual rather than estimated hours and volumespumped in contrast to the calculation of process block 60.

Referring now to FIGS. 2 and 6, the upper surface of the lower clampportion 20 may provide for a shallow tray having upstanding peripherallongitudinally-opposed end walls 90 and 92, these walls separating theopposed upstanding peripheral longitudinally-extending sidewalls 94 and96. The end walls 90 may include notches receiving retention bushings 98a and 98 formed in the IV line 14 to prevent longitudinal movement ofthe IV line 14 with respect to the lower clamp portion 20 along thelongitudinal axis 22.

Between the bushings 98 a and 98 b, the material of the IV line 14 maybe replaced with a silicon material that is softer and more conducive toperistaltic pumping and through-wall pressure sensing. The portion ofthe IV line 14 within the tray of the lower clamp portion 20 may be heldby guides 100 which form notches to align and retain the IV line 14 withthe peristaltic plunger elements 44 and the downwardly extendingoperators of the pressure sensors 46 and 48 held in the bottom wall 101of upper electronics portion 18. The guides 100 may also provide forbackstops holding the IV line 14 against the pressure of the downwardlyextending operators of the pressure sensors 46 and 48 and theperistaltic plunger elements 44.

The IV line 14 may pass through a spring bias clamp element 102 thatautomatically clamps the IV line 14 when the lower clamp portion 20 isseparated from the upper electronics portion 18.

Rear sidewall 96 includes upwardly extending open hinge collars 104spaced along its edge that may attached to and hinge about hinge pin 106supported at a rear edge of the bottom wall 101 of the upper electronicsportion 18, spaced below the bottom wall 101 and generally parallel tothe longitudinal axis 22.

Front sidewall 94 includes longitudinally-extending tabs 107 that may beengaged by corresponding hooks 108 extending down from the front edge ofthe bottom wall 101 of the upper electronics portion 18 and activated byrelease slide 32 as will be described to move generally along thelongitudinal axis 22. When the lower clamp portion 20 is attached by theinterconnection of open hinge collars 104 and hinge pin 106 and pivotedupward toward the bottom 101, the hooks 108 may pass over and attach tothe tabs 107 to retain the upper electronics portion 18 and lower clampportion 20 together with the IV line 14 in proper alignment and clamptherebetween.

By attaching the lower clamp portion 20 to the upper electronics portion18 at multiple points across the narrower dimension of the lower clampportion 20, reduced flexure of the lower clamp portion 20 may beobtained (as opposed to attachment at end walls 92 and 90) against theforces of the peristaltic plunger elements 44 and pressure sensors 46and 48 providing better alignment against minor tolerances and reducedflexure caused by the reduced unsupported span of the polymer materialof the lower clamp portion 20. This allows reduced material costs forthe lower clamp portion 20 and provides increased accuracy, for example,in the pressure sensing.

Referring now to FIG. 5, the downwardly extending hooks 108 may beattached to a common driver bar 110 that is longitudinally spring biasedby a spring 112 into engagement with the tabs 107 tending to hold thelower clamp portion 20 against the upper electronics portion 18. The bar110 may communicate with release slide 32 which may be pressed rightwardagainst the biasing spring 112 to allow release of the hooks 108 fromthe tabs 107. Leftward motion of the bar 110 is only possible, however,when safety lock 34 is pressed inward against biasing spring 112 in adirection perpendicular to the longitudinal axis 22 allowing alongitudinally-extending opening 114 in the safety lock 34 to align withthe driver bar 110 permitting rightward movement of an extension of thecommon driver bar 110 through the longitudinally-extending opening 14.Because the motion of the clamp release slide 32 and safety lock 34 arein different directions and they are located in separated positions,accidental release of the lower clamp portion 20 is greatly reduced.

Certain terminology is used herein for purposes of reference only, andthus is not intended to be limiting. For example, terms such as “upper”,“lower”, “above”, and “below” refer to directions in the drawings towhich reference is made. Terms such as “front”, “back”, “rear”, “bottom”and “side”, describe the orientation of portions of the component withina consistent but arbitrary frame of reference which is made clear byreference to the text and the associated drawings describing thecomponent under discussion. Such terminology may include the wordsspecifically mentioned above, derivatives thereof, and words of similarimport. Similarly, the terms “first”, “second” and other such numericalterms referring to structures do not imply a sequence or order unlessclearly indicated by the context. Indication is used herein to mean anytype of sense to indication including an audio alarm, visual display orother computer-controlled activation (motor buzz, etc.)

When introducing elements or features of the present disclosure and theexemplary embodiments, the articles “a”, “an”, “the” and “said” areintended to mean that there are one or more of such elements orfeatures. The terms “comprising”, “including” and “having” are intendedto be inclusive and mean that there may be additional elements orfeatures other than those specifically noted. It is further to beunderstood that the method steps, processes, and operations describedherein are not to be construed as necessarily requiring theirperformance in the particular order discussed or illustrated, unlessspecifically identified as an order of performance. It is also to beunderstood that additional or alternative steps may be employed.

References to “a microprocessor” and “a processor” or “themicroprocessor” and “the processor,” can be understood to include one ormore microprocessors or other types of computers, gate arrays or thelike that can execute programs and communicate with each other.Furthermore, references to memory, unless otherwise specified, caninclude one or more processor-readable and accessible memory elementsand/or components that can be internal to the processor-controlleddevice, external to the processor-controlled device, and can be accessedvia a wired or wireless network. The term manual pushbuttons meansbuttons that may be operated by finger touch or the like includingtouchscreen and passive switch and mechanical switch.

It will be appreciated that the look-ahead operation of the ambulatorypump 10 described herein is consistent both with anticipatory locking ofthe pump so that the pump does not exceed the service values, as well assetting the service values to a value below the actual longest desiredservice value by amount of the typical treatment protocol and allowingthe treatment protocol to exceed the service value once, and thenlocking out pump. In this latter case, the pump lockout anticipates thatthe next treatment protocol would exceed the remaining operating time orvolume (which is a negative value) and need not actually accept a newprotocol.

It is specifically intended that the present invention not be limited tothe embodiments and illustrations contained herein and the claims shouldbe understood to include modified forms of those embodiments includingportions of the embodiments and combinations of elements of differentembodiments as come within the scope of the following claims. All of thepublications described herein, including patents and non-patentpublications, are hereby incorporated herein by reference in theirentireties.

We claim:
 1. An ambulatory infusion pump comprising: a housing holding:(a) an IV line support structure receiving an IV line set communicatingbetween an IV bag and a patient connection; (b) a fluid pumpcommunicating with the IV support structure to pump fluid through the IVline when the IV line is held in the IV line support structure; (c) auser interface for receiving programming commands from a clinician; and(d) an electronic computer communicating with the fluid pump and theuser interface and executing a program stored in non-transient mediumto: (i) monitor operation of the fluid pump to store at least onecumulative pump operation value indicating a cumulative operation of thefluid pump from a time of manufacture of the ambulatory infusion pump;(ii) receive treatment protocol instructions through the user interfacedescribing an intended future operating limit of the fluid pump to pumpfluid through an IV line in a treatment protocol; (iii) determinewhether an amount of operation of the fluid pump necessary to implementreceived treatment protocol instructions will exceed a predeterminedsoftware-enforced service life of the ambulatory fluid pump reduced bythe at least one cumulative pump operation value; and (iv) when theamount of operation of the fluid pump necessary to implement thetreatment protocol exceeds the software-enforced service life of theambulatory fluid pump reduced by the at least one cumulative pumpoperation value; prevent operation of the fluid pump.
 2. The ambulatoryinfusion pump of claim 1 further providing an indication to anindividual providing the fluid pump operation instructions through theuser interface that the pump has rejected the received treatmentprotocol instructions.
 3. The ambulatory infusion pump of claim 2wherein the indication is a visual display.
 4. The ambulatory infusionpump of claim 1 wherein the software-enforced service life and the atleast one cumulative pump operation value cannot be reset using the userinterface.
 5. The ambulatory infusion pump of claim 4 wherein thesoftware-enforced service life and the at least one cumulative pumpoperation value are stored in nonvolatile memory.
 6. The ambulatoryinfusion pump of claim 5 wherein the software-enforced service life andthe at least one cumulative pump operation value cannot be alteredwithout disassembly of the pump to access internal electroniccomponents.
 7. The ambulatory infusion pump of claim 1 wherein thesoftware-enforced service life and the at least one cumulative pumpoperation value are units of volume of fluid pumped by the fluid pump.8. The ambulatory infusion pump of claim 7 wherein the software-enforcedservice life is a predetermined value of less than 100 liters.
 9. Theambulatory infusion pump of claim 1 wherein the software-enforcedservice life and the at least one cumulative pump operation value areunits of time of operation of the fluid pump.
 10. The ambulatoryinfusion pump of claim 9 wherein the software-enforced service life isless than a predetermined value of 1000 hours.
 11. The ambulatoryinfusion pump of claim 9 wherein the software-enforced service life andcumulative pump operation value are a combination of volume of fluidpumped by the fluid pump and time of operation of the fluid pump andwherein the program step (iii) compares both a volume of fluid to bepumped by the fluid pump needed to implement the treatment protocolagainst a volume of fluid of the software-enforced service life, and atime of operation of the fluid pump needed to implement the treatmentprotocol against a time of operation of the of the software-enforcedservice life, each reduced by respective cumulative pump operationvalues; and (iv) when the amount of operation of the fluid pumpnecessary to implement the treatment protocol exceeds either of thereduced software-enforced service lives of the ambulatory fluid pump,prevent operation of the fluid pump.
 12. The ambulatory infusion pump ofclaim 1 wherein the program further operates to allow entry through theuser interface of a maximum flow rate for delivering medicament bycontrol of the fluid pump according to that value.
 13. The ambulatoryinfusion pump of claim 1 wherein the user interface consists solely ofmanually operated electronic switches receiving user input.
 14. Theambulatory infusion pump of claim 13 wherein the computer programfurther executes to require entry of a password sequence through theuser interface for accepting or changing treatment protocolinstructions.
 15. The ambulatory infusion pump of claim 14 wherein thepassword sequence makes use of manually operated switches labeled forother purposes.
 16. The ambulatory infusion pump of claim 1 wherein thehousing further holds a battery for operating all electronics of theambulatory infusion pump.
 17. The ambulatory infusion pump of claim 1wherein the pump has a total weight less than one pound.
 18. Theambulatory infusion pump of claim 1 wherein the housing provides agenerally rectangular volume having an upper active portion and a lowerclamp portion attachable to the upper active portion to hold the IV linetherebetween extending along a longitudinal axis and wherein the upperactive portion and lower clamp portion releasably attach to each otherat multiple points along opposed longitudinal interfacing edges.
 19. Theambulatory infusion pump of claim 1 wherein the upper active portion andlower clamp portion releasably attach along a front longitudinal edge byinter-engaging sliding hooks and tabs and wherein a front face of thehousing exposes a slide operator movable in a first direction to slidethe hooks and a safety stop movable against a spring in a seconddirection different from the first direction to a state allowing slidingof the hooks; whereby two distinct operations are required to releasethe lower clamp portion.